How Dangerous Is Hydroxycut?

On May 1, 2009, the US Food andDrug Administration (FDA) issued a press release urging consumers to stopusing 14 varieties of the diet aid Hydroxycut and return unused portions to theplace of purchase.  The FDA also sent aletter to health care professionals stating that officials "believe[Hydroxycut] presents a serious public health risk."  In response, the manufacturer of Hydroxycut,Iovate Health Sciences, Inc., decided to issue a voluntary recall of allproducts named by the FDA.  But just howdangerous is Hydroxycut, really?  Was theFDA justified in its action, or is this an overhasty response to a minor healthconcern.

About Hydroxycut Injuries

The main rationale for the FDA's actionregarding Hydroxycut is liver damage. In some patients it seems to create acute liver toxicity that requiredhospitalization in more than 2/3 of the reported cases, and required livertransplants for two of them.  One of thepatients was deemed unsuitable for a liver transplant because of significantdamage to other organs.  This patient, a17-year old male, had taken an elevated dose of Hydroxycut, and died after thedecision was made not to pursue the liver transplant.

In addition to liver damage, the FDA determined that anumber of serious illnesses have been associated with Hydroxycut use, includingcardiovascular injury, seizures, and severe muscle damage known asrhabdomyolysis. 

The Numbers ofHydroxycut Injuries

In its press releases and statements, the FDA claims therehave been 23 cases of confirmed liver damage resulting from the use ofHydroxycut.  The cases appeared over a sevenyear period.  With millions of bottles ofHydroxycut being sold every year, the number of injuries may seem very small,making many believe that FDA's statement and subsequent recall is something ofan overreaction.

The Rationale for theHydroxycut Action

Hydroxycut seems to cause what is known as idiosyncraticliver toxicity, a condition which is inherently very rare.  The toxic reaction occurs in less than 10people per 100,000, and often in less than 1 per 100,000.  Although toxic reactions are rare,idiosyncratic liver toxicity is the most common form of drug-induced livertoxicity because it is unpredictable, generally undetected in clinical trials,and often occurs with only recommended doses of a drug.

In addition, the FDA did not know what ingredient ofHydroxycut was responsible for the liver toxicity.  It did not know whether liver toxicity wasthe result of a biologic extract or a heavy metal.  It did not even know whether the toxicity mayhave been the result of contaminated or badly blended pills.  Reports of liver damage have been associatedwith Hydroxycut since its introduction, but it was believed at first that theingredient ephedra, associated with seizure, cardiovascular damage, and otheradverse health effects, was responsible for the damage.  But Hydroxycut has been ephedra-free sincethe ingredient was banned in 2004, and reports of liver damage have continued.

Because of all the unknowns, the FDA could not issue aspecific caution that would identify users with an elevated risk fromHydroxycut and thereby reduce future cases of liver toxicity.  The only way the FDA could protect users wasto ask them to stop using Hydroxycut, a request that will likely stay in effectuntil a causative agent can be identified.

So, How Dangerous IsHydroxycut?

We're back to the place we started then, with the questionof how dangerous is this diet aid?  Theanswer is:  no-one knows.  The FDA's action is designed to stop morepeople from suffering adverse, potentially deadly reactions to Hydroxycut whilethe agency and the manufacturer of the supplement determine what is thecause.  Once the ingredient responsiblehas been identified, we can expect Hydroxycut to return to the market eitherreformulated or with specific warnings that may help users make informeddecisions about whether a diet supplement with no proven effectiveness is worththe potential risk.